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Gene-edited monkey embryos give researchers new way to study HIV cure – University of Wisconsin-Madison

By daniellenierenberg

Egg cells harvested from Mauritian cynomolgus macaques (top left) were fertilized (top right) and injected with CRISPR gene editing materials to insert a genetic mutation that cured two men of HIV in the last decade. The growing embryos (developing in the bottom images), if carried to maturity by surrogates, will help researchers study the mutation as a potential treatment for HIV. Courtesy of Golos and Slukvin labs

A gene that cured a man of HIV a decade ago has been successfully added to developing monkey embryos in an effort to study more potential treatments for the disease.

Timothy Brown, known for years as the Berlin Patient, received a transplant of bone marrow stem cells in 2007 to treat leukemia. The cells came from a donor with a rare genetic mutation that left the surfaces of their white blood cells without a protein called CCR5. When Browns immune system was wiped out and replaced by the donated cells, his new immune systems cells carried the altered gene.

This mutation cuts a chunk out of the genome so that it loses a functional gene, CCR5, that is a co-receptor for HIV, says Ted Golos, a University of WisconsinMadison reproductive scientist and professor of comparative biosciences and obstetrics and gynecology. Without CCR5, the virus cant attach to and enter cells to make more HIV. So, in Timothy Browns case, his infection was eliminated.

In 2019, a second cancer patient Adam Castillejo, initially identified as the London patient was cleared of his HIV by a stem cell transplant conferring the same mutation.

Thats very exciting, and there have been some follow up studies. But its been complicated, to say the least, Golos says.

Between the two transplants came a more infamous application of the mutation, when in 2018 Chinese biophysicist He Jiankui announced he had used the DNA-editing tool CRISPR to write the mutation into the DNA of a pair of human embryos. His work drew criticism from scientists concerned with the ethics of altering genes that can be passed down to human offspring, and he was jailed by the Chinese government for fraud.

The promise of the CCR5 mutation remains, but not without further study. The mutation occurs naturally in fewer than 1 percent of people, suggesting that it may not be associated only with positive health outcomes. An animal model for research can help answer open questions.

Given interest in moving forward gene-editing technologies for correcting genetic diseases, preclinical studies of embryo editing in nonhuman primates are very critical, says stem cell researcher Igor Slukvin, a UWMadison professor of pathology and laboratory medicine.

Golos, Slukvin and colleagues at UWMadisons Wisconsin National Primate Research Center and schools of Veterinary Medicine and Medicine and Public Health employed CRISPR to edit the DNA in newly fertilized embryos of cynomolgus macaque monkeys. They published their work recently in the journal Scientific Reports.

Slukvins lab had already established a method for slicing the CCR5-producing gene out of the DNA in human pluripotent stem cells, which can be used to generate immune cells resistant to HIV.

We used that same targeting construct that we already knew worked in cells, and delivered it to one-cell fertilized embryos, says Jenna Kropp Schmidt, a Wisconsin National Primate Research Center scientist. The thought is that if you make the genetic edit in the early embryo that it should propagate through all the cells as the embryo grows.

Primate Center scientist Nick Strelchenko found that as much as one-third of the time the gene edits successfully deleted the sections of DNA in CRISPRs crosshairs base pairs in both of the two copies of the CCR5 gene on a chromosome and were carried on into new cells as the embryos grew.

The goal now is to transfer these embryos into surrogates to produce live offspring who carry the mutation, Schmidt says.

Cynomolgus macaques are native to Southeast Asia, but a group of the monkeys has lived in isolation on the Indian Ocean island of Mauritius for about 500 years. Because the entire Mauritian monkey line descends from a small handful of founders, they have just seven variations of the major histocompatibility complex, the group of genes that must be matched between donor and recipient for a successful bone marrow transplant. There are hundreds of MHC variations in humans.

With MHC-matched monkeys carrying the CCR5 mutation, the researchers would have a reliable way to study how successful the transplants are against the simian immunodeficiency virus, which works in monkeys just like HIV does in humans.

Anti-retroviral drugs have really positively changed the expectation for HIV infection, but in some patients, they may not be as effective. And theyre certainly not without long-term consequences, says Golos, whose work is funded by the National Institutes of Health. So, this is potentially an alternative approach, which also allows us to expand our understanding of the immune system and how it might protect people from HIV infection.

The animal model could lead to the development of gene-edited human hematopoietic stem cells the type that work in bone marrow to produce many kinds of blood cells that Slukvin and Golos say could be used as an off-the-shelf treatment for HIV infection.

This research was supported by grants from the National Institutes of Health (R24OD021322, P51OD011106, K99 HD099154-01, RR15459-01 and RR020141-01).

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Hematopoietic Stem Cell Transplantation (HSCT) Market by Product Type, End User and by Region-Trends and Forecast to 2026|China Cord Blood Corp, CBR…

By daniellenierenberg

The global Hematopoietic Stem Cell Transplantation (HSCT) market is broadly analyzed in this report that sheds light on critical aspects such as the vendor landscape, competitive strategies, market dynamics, and regional analysis. The report helps readers to clearly understand the current and future status of the global Hematopoietic Stem Cell Transplantation (HSCT) market. The research study comes out as a compilation of useful guidelines for players to secure a position of strength in the global Hematopoietic Stem Cell Transplantation (HSCT) market. The authors of the report profile leading companies of the global Hematopoietic Stem Cell Transplantation (HSCT) market, such as Regen Biopharma Inc, China Cord Blood Corp, CBR Systems Inc, Escape Therapeutics Inc, Cryo-Save AG, Lonza Group Ltd, Pluristem Therapeutics Inc, ViaCord Inc They provide details about important activities of leading players in the competitive landscape.

The report predicts the size of the global Hematopoietic Stem Cell Transplantation (HSCT) market in terms of value and volume for the forecast period 2019-2026. As per the analysis provided in the report, the global Hematopoietic Stem Cell Transplantation (HSCT) market is expected to rise at a CAGR of XX % between 2019 and 2026 to reach a valuation of US$ XX million/billion by the end of 2026. In 2018, the global Hematopoietic Stem Cell Transplantation (HSCT) market attained a valuation of US$_ million/billion. The market researchers deeply analyze the global Hematopoietic Stem Cell Transplantation (HSCT) industry landscape and the future prospects it is anticipated to create.

This publication includes key segmentations of the global Hematopoietic Stem Cell Transplantation (HSCT) market on the basis of product, application, and geography (country/region). Each segment included in the report is studied in relation to different factors such as consumption, market share, value, growth rate, and production.

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The comparative results provided in the report allow readers to understand the difference between players and how they are competing against each other. The research study gives a detailed view of current and future trends and opportunities of the global Hematopoietic Stem Cell Transplantation (HSCT) market. Market dynamics such as drivers and restraints are explained in the most detailed and easiest manner possible with the use of tables and graphs. Interested parties are expected to find important recommendations to improve their business in the global Hematopoietic Stem Cell Transplantation (HSCT) market.

Readers can understand the overall profitability margin and sales volume of various products studied in the report. The report also provides the forecasted as well as historical annual growth rate and market share of the products offered in the global Hematopoietic Stem Cell Transplantation (HSCT) market. The study on end-use application of products helps to understand the market growth of the products in terms of sales.

Global Hematopoietic Stem Cell Transplantation (HSCT) Market by Product: , Allogeneic, Autologous

Global Hematopoietic Stem Cell Transplantation (HSCT) Market by Application: Peripheral Blood Stem Cells Transplant (PBSCT), Bone Marrow Transplant (BMT), Cord Blood Transplant (CBT)

The report also focuses on the geographical analysis of the global Hematopoietic Stem Cell Transplantation (HSCT) market, where important regions and countries are studied in great detail.

Global Hematopoietic Stem Cell Transplantation (HSCT) Market by Geography:

Methodology

Our analysts have created the report with the use of advanced primary and secondary research methodologies.

As part of primary research, they have conducted interviews with important industry leaders and focused on market understanding and competitive analysis by reviewing relevant documents, press releases, annual reports, and key products.

For secondary research, they have taken into account the statistical data from agencies, trade associations, and government websites, internet sources, technical writings, and recent trade information.

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Table Of Contents:

1 Market Overview of Hematopoietic Stem Cell Transplantation (HSCT)1.1 Hematopoietic Stem Cell Transplantation (HSCT) Market Overview1.1.1 Hematopoietic Stem Cell Transplantation (HSCT) Product Scope1.1.2 Market Status and Outlook1.2 Global Hematopoietic Stem Cell Transplantation (HSCT) Market Size Overview by Region 2015 VS 2020 VS 20261.3 Global Hematopoietic Stem Cell Transplantation (HSCT) Market Size by Region (2015-2026)1.4 Global Hematopoietic Stem Cell Transplantation (HSCT) Historic Market Size by Region (2015-2020)1.5 Global Hematopoietic Stem Cell Transplantation (HSCT) Market Size Forecast by Region (2021-2026)1.6 Key Regions, Hematopoietic Stem Cell Transplantation (HSCT) Market Size YoY Growth (2015-2026)1.6.1 North America Hematopoietic Stem Cell Transplantation (HSCT) Market Size YoY Growth (2015-2026)1.6.2 Europe Hematopoietic Stem Cell Transplantation (HSCT) Market Size YoY Growth (2015-2026)1.6.3 Asia-Pacific Hematopoietic Stem Cell Transplantation (HSCT) Market Size YoY Growth (2015-2026)1.6.4 Latin America Hematopoietic Stem Cell Transplantation (HSCT) Market Size YoY Growth (2015-2026)1.6.5 Middle East & Africa Hematopoietic Stem Cell Transplantation (HSCT) Market Size YoY Growth (2015-2026) 2 Hematopoietic Stem Cell Transplantation (HSCT) Market Overview by Type2.1 Global Hematopoietic Stem Cell Transplantation (HSCT) Market Size by Type: 2015 VS 2020 VS 20262.2 Global Hematopoietic Stem Cell Transplantation (HSCT) Historic Market Size by Type (2015-2020)2.3 Global Hematopoietic Stem Cell Transplantation (HSCT) Forecasted Market Size by Type (2021-2026)2.4 Allogeneic2.5 Autologous 3 Hematopoietic Stem Cell Transplantation (HSCT) Market Overview by Application3.1 Global Hematopoietic Stem Cell Transplantation (HSCT) Market Size by Application: 2015 VS 2020 VS 20263.2 Global Hematopoietic Stem Cell Transplantation (HSCT) Historic Market Size by Application (2015-2020)3.3 Global Hematopoietic Stem Cell Transplantation (HSCT) Forecasted Market Size by Application (2021-2026)3.4 Peripheral Blood Stem Cells Transplant (PBSCT)3.5 Bone Marrow Transplant (BMT)3.6 Cord Blood Transplant (CBT) 4 Global Hematopoietic Stem Cell Transplantation (HSCT) Competition Analysis by Players4.1 Global Hematopoietic Stem Cell Transplantation (HSCT) Market Size by Players (2015-2020)4.2 Global Top Manufacturers by Company Type (Tier 1, Tier 2 and Tier 3) (based on the Revenue in Hematopoietic Stem Cell Transplantation (HSCT) as of 2019)4.3 Date of Key Manufacturers Enter into Hematopoietic Stem Cell Transplantation (HSCT) Market4.4 Global Top Players Hematopoietic Stem Cell Transplantation (HSCT) Headquarters and Area Served4.5 Key Players Hematopoietic Stem Cell Transplantation (HSCT) Product Solution and Service4.6 Competitive Status4.6.1 Hematopoietic Stem Cell Transplantation (HSCT) Market Concentration Rate4.6.2 Mergers & Acquisitions, Expansion Plans 5 Company (Top Players) Profiles and Key Data5.1 Regen Biopharma Inc5.1.1 Regen Biopharma Inc Profile5.1.2 Regen Biopharma Inc Main Business5.1.3 Regen Biopharma Inc Hematopoietic Stem Cell Transplantation (HSCT) Products, Services and Solutions5.1.4 Regen Biopharma Inc Hematopoietic Stem Cell Transplantation (HSCT) Revenue (US$ Million) & (2015-2020)5.1.5 Regen Biopharma Inc Recent Developments5.2 China Cord Blood Corp5.2.1 China Cord Blood Corp Profile5.2.2 China Cord Blood Corp Main Business5.2.3 China Cord Blood Corp Hematopoietic Stem Cell Transplantation (HSCT) Products, Services and Solutions5.2.4 China Cord Blood Corp Hematopoietic Stem Cell Transplantation (HSCT) Revenue (US$ Million) & (2015-2020)5.2.5 China Cord Blood Corp Recent Developments5.3 CBR Systems Inc5.5.1 CBR Systems Inc Profile5.3.2 CBR Systems Inc Main Business5.3.3 CBR Systems Inc Hematopoietic Stem Cell Transplantation (HSCT) Products, Services and Solutions5.3.4 CBR Systems Inc Hematopoietic Stem Cell Transplantation (HSCT) Revenue (US$ Million) & (2015-2020)5.3.5 Escape Therapeutics Inc Recent Developments5.4 Escape Therapeutics Inc5.4.1 Escape Therapeutics Inc Profile5.4.2 Escape Therapeutics Inc Main Business5.4.3 Escape Therapeutics Inc Hematopoietic Stem Cell Transplantation (HSCT) Products, Services and Solutions5.4.4 Escape Therapeutics Inc Hematopoietic Stem Cell Transplantation (HSCT) Revenue (US$ Million) & (2015-2020)5.4.5 Escape Therapeutics Inc Recent Developments5.5 Cryo-Save AG5.5.1 Cryo-Save AG Profile5.5.2 Cryo-Save AG Main Business5.5.3 Cryo-Save AG Hematopoietic Stem Cell Transplantation (HSCT) Products, Services and Solutions5.5.4 Cryo-Save AG Hematopoietic Stem Cell Transplantation (HSCT) Revenue (US$ Million) & (2015-2020)5.5.5 Cryo-Save AG Recent Developments5.6 Lonza Group Ltd5.6.1 Lonza Group Ltd Profile5.6.2 Lonza Group Ltd Main Business5.6.3 Lonza Group Ltd Hematopoietic Stem Cell Transplantation (HSCT) Products, Services and Solutions5.6.4 Lonza Group Ltd Hematopoietic Stem Cell Transplantation (HSCT) Revenue (US$ Million) & (2015-2020)5.6.5 Lonza Group Ltd Recent Developments5.7 Pluristem Therapeutics Inc5.7.1 Pluristem Therapeutics Inc Profile5.7.2 Pluristem Therapeutics Inc Main Business5.7.3 Pluristem Therapeutics Inc Hematopoietic Stem Cell Transplantation (HSCT) Products, Services and Solutions5.7.4 Pluristem Therapeutics Inc Hematopoietic Stem Cell Transplantation (HSCT) Revenue (US$ Million) & (2015-2020)5.7.5 Pluristem Therapeutics Inc Recent Developments5.8 ViaCord Inc5.8.1 ViaCord Inc Profile5.8.2 ViaCord Inc Main Business5.8.3 ViaCord Inc Hematopoietic Stem Cell Transplantation (HSCT) Products, Services and Solutions5.8.4 ViaCord Inc Hematopoietic Stem Cell Transplantation (HSCT) Revenue (US$ Million) & (2015-2020)5.8.5 ViaCord Inc Recent Developments 6 North America6.1 North America Hematopoietic Stem Cell Transplantation (HSCT) Market Size by Country6.2 United States6.3 Canada 7 Europe7.1 Europe Hematopoietic Stem Cell Transplantation (HSCT) Market Size by Country7.2 Germany7.3 France7.4 U.K.7.5 Italy7.6 Russia7.7 Nordic7.8 Rest of Europe 8 Asia-Pacific8.1 Asia-Pacific Hematopoietic Stem Cell Transplantation (HSCT) Market Size by Region8.2 China8.3 Japan8.4 South Korea8.5 Southeast Asia8.6 India8.7 Australia8.8 Rest of Asia-Pacific 9 Latin America9.1 Latin America Hematopoietic Stem Cell Transplantation (HSCT) Market Size by Country9.2 Mexico9.3 Brazil9.4 Rest of Latin America 10 Middle East & Africa10.1 Middle East & Africa Hematopoietic Stem Cell Transplantation (HSCT) Market Size by Country10.2 Turkey10.3 Saudi Arabia10.4 UAE10.5 Rest of Middle East & Africa 11 Hematopoietic Stem Cell Transplantation (HSCT) Market Dynamics11.1 Industry Trends11.2 Market Drivers11.3 Market Challenges11.4 Market Restraints 12 Research Finding /Conclusion 13 Methodology and Data Source 13.1 Methodology/Research Approach13.1.1 Research Programs/Design13.1.2 Market Size Estimation13.1.3 Market Breakdown and Data Triangulation13.2 Data Source13.2.1 Secondary Sources13.2.2 Primary Sources13.3 Disclaimer13.4 Author List

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Ruxolitinib for Acute Graft-vs-Host Disease Improves Outcomes in the Second Line – Targeted Oncology

By daniellenierenberg

During a Targeted Oncology Case Based Peer Perspective event, Usama Gergis, MD, MBA, professor of Oncology, director, Bone Marrow Transplant and Immune Cellular Therapy at Sidney Kimmel Cancer Center, at the Thomas Jefferson University Hospital, discussed the case of a 48-year-old male patient with acute graft-versus-host-disease (GVHD).

Targeted Oncology: For a patient such as this, what is the risk of developing acute (GVHD) following transplant?

GERGIS: The list of risk factors for GVHD is huge: donor HLA [human leukocyte antigen] disparities that are major/minor, sex matching, donor parity, donor age, blood typewhile its controversialdonor CMV seropositivity, gene polymorphism, and stemcell graft source. Obviously, peripheral mobilized stem cells have more T cells than bone marrow. Other factors include graft composition, the higher CD34 the higher lymphocytes, and conditioning intensities. There are a bunch of factors here, at least for our patient, who had a MAC. The fact that his donor is a multirisk, 50-year-old woman and a MUD [infers] similar higher risk.

How quickly do you determine whether a patient is steroid refractory or steroid dependent?

Basically, steroid refractoriness or resistance versus dependence versus intolerance [can be determined in] as early as 3 days. If there is progression of the grade of GVHD, this is considered steroid refractory. If by 4 weeks it does not go to grade 0, its considered refractory. However, I disagree with the 28-day [timeline]. I think its a long time to wait. Usually, I look at 2 weeks.

This has been the consensus among many of us. I think the trials REACH-1 [NCT02953678] and REACH-2 [NCT02435433] looked at 28 days; but if you go to the 2 papers, most responses took place in 7 to 14 days. Again, this is in the second-line setting.

Ive been doing this for 15 years. Ive been through most of this; so many lines [of therapy and] so many heartbreaks. I teach my fellows to look at any [research] paper in second-line GVHDthe overall response rate is 30%. Ive done it with MMF [mycophenolate mofetil], sirolimus [Rapamune], infliximab [Remicade], ATG [antithymocyte globulin], cyclophosphamide, Ontak [denileukin diftitox], and mesenchymal stem cells and overall response rate is 30%.

Which data support the use of ruxolitinib (Jakafi) in patients who are steroid refractory?

Based on a small trial of 49 patients, a phase 2 trial [INCB 18424-271; NCT02953678], ruxolitinib was approved as a second-line therapy for patients with acute steroid-refractory GVHD.1

Review the details of the REACH-2 trial.

The REACH-2 trial data were just published in 2020. Ruxolitinib was approved based on a small trial of 49 patients with steroid-refractory acute GVHD. They enrolled 70 but only 49 were available for efficacy. Obviously, it was a pilot phase 2 with no comparative arm, and the response rates across the board were [somewhere in the range of] 50% or so by day 28.

Then they were asked to run a phase 3 trial comparing ruxolitinib at 10 mg twice daily versus best available care. The best available care goes through the list that I just mentioned, including photopheresis, ATG, and others. After 4 weeks, patients who were not responders on the best available care were allowed to cross over to ruxolitinib.

By day 28, the responders on the ruxolitinib composed 60% of the cohort versus 40% on the control arm with a P value of less than .001. The durability of response at 8 weeks was 40% versus 20% [odds ratio, 2.38; 95% CI, 1.43 to 3.94; P < .001].

This tell us that ruxolitinib works in this group, that it does not work that great in one-third of patients who lose their response at 8 weeks, and that its just better than anything else [thats available]. A good thing about the ruxolitinib arm is that the response duration was much longer than best available treatment, as illustrated by the Kaplan-Meier curve for response duration.

Failure-free survival [in this trial] was 5.0 months versus 1.0 month [HR, 0.46; 95% CI, 0.35-0.60].

Do you apply this therapy to any of your patients?

We have a patient [at my institution] who has steroid-refractory GVHD. Last Friday in our weekly meeting, we were discussing his [case]. He has lower GI [gastrointestinal] GVHDgrade IV, steroid-refractory, as bad as it getsand I said lets start him on ruxolitinib. One of my colleagues said it doesnt work well in the lower GI. I asked the organizers to pull [data] from the supplemental figures on the New England Journal of Medicine paper of REACH-2 [indicating that these patients did have a benefit with ruxolitinib].2

REFERENCES:

1. FDA approves ruxolitinib for acute graft-versus-host disease. FDA. May 24, 2019. Accessed October 10, 2020. https://bit.ly/2SMU7I8

2. Zeiser R, von Bubnoff N, Butler J, et al; REACH2 Trial Group. Ruxolitinib for glucocorticoid- refractory acute graft-versus-host disease. N Engl J Med. 2020;382(19):1800-1810. doi: 10.1056/NEJMoa1917635

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Cord Stem Cell Banking Market 2020-2026 is Growing Globally With Lifecell, StemCyte India Therapeutics Pvt. Ltd, Viacord, SMART CELLS PLUS., Cryoviva…

By daniellenierenberg

Global Cord Stem Cell Banking Market report brings into light key market dynamics of the sector. It provides guidelines about planning of advertising and sales promotion efforts. The market report is a professional yet exhaustive study on the current state for the market. This world class market research report is a vital document in planning business objectives or goals. The credible market report is a window to the industry which talks about what market definition, classifications, applications, engagements and market trends are. While formulating this Cord Stem Cell Banking Market analysis report, client business competence is understood adeptly to identify tangible growth opportunities.

The wide ranging Cord Stem Cell Banking Market report evaluates CAGR value fluctuation during the forecast period of 2021-2028 for the market. All the data of research and analysis are mapped in an actionable model, with strategic recommendations from the experts. Base year for calculation in the report is considered as 2020 while the historic year is 2019 which will tell how the Cord Stem Cell Banking Market is going to act upon in the forecast years by giving information about the several market insights. Lastly, the large scale report makes some important proposals for a new project of the market before evaluating its feasibility.

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Global Cord stem cell banking market is estimated to reach USD 13.8 billion by 2026 registering a healthy CAGR of 22.4%. The increasing number of parents storing their childs cord blood, acceptance of stem cell therapeutics, high applicability of stem cells are key driver to the market.

Few of the major market competitors currently working in the globalcord stem cell banking marketareCBR Systems, Inc., Cordlife, Cells4Life Group LLP, Cryo-Cell International, Inc., Cryo-Save AG, Lifecell, StemCyte India Therapeutics Pvt. Ltd, Viacord, SMART CELLS PLUS., Cryoviva India, Global Cord Blood Corporation, National Cord Blood Program, Vita 34, ReeLabs Pvt. Ltd., Regrow Biosciences Pvt. Ltd. , ACROBiosystems., Americord Registry LLC., New York Blood Center, Maze Cord Blood, GoodCell., AABB, Stem Cell Cryobank, New England Cryogenic Center, Inc. among others

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Market Definition: Global Cord Stem Cell Banking Market

Cord stem cells banking is nothing but the storing of the cord blood cell contained in the umbilical cord and placenta of a newborn child. This cord blood contains the stem cells which can be used in future to treat disease such as leukemia, thalassemia, autoimmune diseases, and inherited metabolic disorders, and few others.

Segmentation: Global Cord Stem Cell Banking Market

Cord Stem Cell banking Market : By Storage Type

Cord Stem Cell banking Market : By Product Type

Cord Stem Cell banking Market : By Service Type

Cord Stem Cell banking Market : By Indication

Cord Stem Cell banking Market : By Source

Cord Stem Cell banking Market : By Geography

Key Developments in the Cord Stem Cell banking Market:

Cord Stem Cell banking Market : Drivers

Cord Stem Cell banking Market : Restraint

Scope of the Cord Stem Cell banking Market Report :

The report shields the development activities in the Cord Stem Cell banking Market which includes the status of marketing channels available, and an analysis of the regional export and import. It helps in making informed business decisions by having complete insights of market and by making in-depth analysis of market segments. This will benefit the reports users, that evaluates their position in Cord Stem Cell banking market as well as create effective strategies in the near future.

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Cord Stem Cell Banking Market 2020-2026 is Growing Globally With Lifecell, StemCyte India Therapeutics Pvt. Ltd, Viacord, SMART CELLS PLUS., Cryoviva...

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Stem Cell Banking Market is Projected to Reach $6,956 million by 2023 | Leading key players are Cord Blood Registry, ViaCord, Cryo-Cell, China Cord…

By daniellenierenberg

The global stem cell banking market was valued at $1,986 million in 2016, and is estimated to reach $6,956 million by 2023, registering a CAGR of 19.5% from 2017 to 2023. Stem cell banking is a process where the stem cell care isolated from different sources such as umbilical cord and bone marrow that is stored and preserved for future use. These cells can be cryo-frozen and stored for decades. Private and public banks are different types of banks available to store stem cells.

Top Companies Covered in this Report: Cord Blood Registry, ViaCord, Cryo-Cell, China Cord Blood Corporation, Cryo-Save, New York Cord Blood Program, CordVida, Americord, CryoHoldco, Vita34

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Increase in R&D activities in regards with applications of stem cells and increase in prevalence of fatal chronic diseases majorly drive the growth of the global stem cell banking market. Moreover, the large number of births occurring globally and growth in GDP & disposable income help increase the number of stem cell units stored, which would help fuel the market growth. However, legal and ethical issues related to stem cell collections and high processing & storage cost are projected to hamper the market growth. The initiative taken by organizations and companies to spread awareness in regards with the benefits of stem cells and untapped market in the developing regions help to open new avenues for the growth of stem cell banking market in the near future.

The global stem cell banking market is segmented based on cell type, bank type, service type, utilization, and region. Based on cell type, the market is classified into umbilical cord stem cells, adult stem cells, and embryonic stem cells. Depending on bank type, it is bifurcated into public and private. By service type, it is categorized into collection & transportation, processing, analysis, and storage. By utilization, it is classified into used and unused. Based on region, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

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Table Of Content

CHAPTER 1: INTRODUCTION

CHAPTER 2: EXECUTIVE SUMMARY

CHAPTER 3: MARKET OVERVIEW

CHAPTER 4: STEM CELL BANKING MARKET, BY CELL TYPE

CHAPTER 5: STEM CELL BANKING MARKET, BY BANK TYPE

CHAPTER 6: STEM CELL BANKING MARKET, BY SERVICE TYPE

CHAPTER 7: STEM CELL BANKING MARKET, BY UTILIZATION

CHAPTER 8: STEM CELL BANKING MARKET, BY REGION

CHAPTER 9: COMPANY PROFILES

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Stem Cell Banking Market is Projected to Reach $6,956 million by 2023 | Leading key players are Cord Blood Registry, ViaCord, Cryo-Cell, China Cord...

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BRTX-100; the Story of BioRestorative Therapies Inc (OTCMKTS: BRTX) – MicroCap Daily

By daniellenierenberg

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BioRestorative Therapies Inc (OTCMKTS: BRTXQ) (BRTX) is soaring up the charts after it was revealed at 12.04 pm Wednesday afternoon the Company was emerging from bankruptcy. BRTXQ came to the attention of many penny stock speculators after the Company partnered on a new bankruptcy reorganization plan with one of its creditors Auctus Capital in which it would emerge from bankruptcy with the commons intact, ready to begin phase 2 trials and get BioRestorative back on a national stock exchange.

BioRestorative Therapies has received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat persistent lower back pain due to painful degenerative discs. BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. It is the Companys intend that the product be used for the non-surgical treatment of painful lumbosacral disc disorders.

BioRestorative Therapies Inc (OTCMKTS: BRTX) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders: Disc/Spine Program (brtxDISC): Its lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders.

The BRTX-100 production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. The Company has received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat persistent lower back pain due to painful degenerative discs.

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Metabolic Program (ThermoStem): the Company is developing a cell-based therapy to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

BioRestorative owns a valuable intelectual property portfolio including unique international Stem Cell patents as well as 8 patents issued, in the United States and other countries, for the Companys brown fat technology related to BioRestoratives metabolic program (ThermoStem Program).

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BioRestorative Therapies is making a powerful move up the charts after it was it was revealed at 12.04 pm Wednesday afternoon the Company was emerging from bankruptcy. This comes after the Company successfully entered into a reorganization plan with one of its creditors Auctus Capital after its March Bankruptcy filing in which the Company would emerge from bankruptcy with the commons intact, ready to begin their phase 2 trials and get BioRestorative back on a national stock exchange. BioRestorative Therapies has received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat persistent lower back pain due to painful degenerative discs. BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. It is the Companys intend that the product be used for the non-surgical treatment of painful lumbosacral disc disorders. We will be updating on BioRestorative when more details emerge so make sure you are subscribed to Microcapdaily so you know whats going on with BioRestorative.

Disclosure: we hold no position in BRTX either long or short and we have not been compensated for this article.

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Non-hereditary mutation acts as natural gene therapy for GATA2 deficiency – Health Europa

By daniellenierenberg

For the first time, researchers at the Center for Cell-Based Therapy (CTC) in Ribeiro Preto, Brazil, have identified a non-hereditary mutation in blood cells from a patient with GATA2 deficiency.

GATA2 deficiency is a rare autosomal disease caused by inherited mutations in the gene that encodes GATA-binding protein 2 (GATA2), which regulates the expression of genes that play a role in developmental processes and cell renewal.

An article on the study is publishedin the journalBlood.

The non-hereditary mutation may have acted as a natural gene therapy which prevented the disease from damaging the process of blood cell renewal. This meant that the patient did not develop such typical clinical manifestations as bone marrow failure, hearing loss, and lymphedema.

The researchers say that the findings pave the way for the use of gene therapy and changes to the process of checking family medical history and medical records for families with the hereditary disorder.

Luiz Fernando Bazzo Catto, first author of the article, said: When a germline [inherited] mutation in GATA2 is detected, the patients family has to be investigated because there may be silent cases.

The discovery was made when two sons were receiving medical treatment at the blood centre of the hospital run by FMRP-USP, both of which, in post-mortem DNA sequencing, showed germline mutations and GATA2 deficiency diagnosis. The researchers used next generation sequencing to estimate the proportion of normal blood cells in the fathers bone marrow, preventing clinical manifestations of GATA2 deficiency, and of cells similar to his childrens showing that 93% of his leukocytes had the mutation that protects from the clinical manifestations of GATA2 deficiency.

Following the sequencing of the fathers T-lymphocytes, the researchers found that the mutation occurred early in their lives and in the development of hematopoietic stem cells, which have the potential to form blood.

They also measured the activity of the blood cells, to see if they could maintain the activity of inducing normal cell production for a long time, by measuring the telomeres of his peripheral blood leukocytes. Telomeres are repetitive sequences of non-coding DNA at the tip of chromosomes that protect them from damage. Each time cells divide, their telomeres become shorter. They eventually become so short that division is no longer possible, and the cells die or become senescent.

The telomeres analysed by the researchers were long, indicating that the cells can remain active for a long time.

The researchers hypothesised that the existence of the somatic mutation in the fathers blood cells, and its restoration of the blood cell renewal process, may have contributed to the non-manifestation of extra-haematological symptoms of GATA2 deficiency such as deafness, lymphedema, and thrombosis.

Professor Rodrigo Calado, a corresponding author of the article, said: A sort of natural gene therapy occurred in this patient. Its as if he embodied an experiment and a medium-term prospect of analogous gene therapy treatment in patients with GATA2 deficiency.

The findings help us understand better how stem cells can recover by repairing an initial genetic defect.

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gift of life marrow registry announces new center for cell and gene therapy – The Boca Raton Tribune

By daniellenierenberg

Chamber Member Update

Boca Raton, FL, November 17 Every three minutes a person in the United States is diagnosed with a blood disease such as leukemia, immunodeficiencies and sickle cell. To deliver cutting-edge, lifesaving therapy services for stem cell transplantations and improve patient outcomes, the Gift of Life Marrow Registry has announced the newly opened the Gift of Life Center for Cell and Gene Therapy.

Located at Gift of Lifesheadquarters in Boca Raton, Fla., theCenter will provide transplant physicians, researchers, and cell and gene therapy developers with the donor cell products they need to help more patients than ever before. One of the Centers signature services will be a biobank of off-the-shelf, on-demand cell therapy products available for transplantation, as well as those for engineering and ethical research. The inventory will be comprised of products collected from super donors with high frequency genetic characteristics sourced from the Gift of Life Marrow Registry. These cells will be tested, processed and cryopreserved by the Centers cellular therapy laboratory.

Another specialty service is the Centers innovation program, which will collaborate with world-renowned South Florida research institutions to improve transplant outcomes, develop processes for cell expansion and much more.

While many advancements have been made in stem cell treatments for those with blood diseases, there are still critical barriers that can impeded success, said Gift of Life CEO and Founder Jay Feinberg.

The only registry in the world started and run by a transplant survivor, Gift of Life has pioneered key innovations in the stem cell transplantation and donation process. Last April, the organization become the first registry to operate an in-house stem cell collection center that has not only helped to bring stem cell donors to collection faster, but also greatly improves the experience for donors. Gift of life is also the first registry to use buccal cheek swabs at recruitment drives instead of blood draws and the first to do mobile registration, including the creation of a smart phone app to register individuals quickly and effectively.

Gift of Lifes overarching mission isto democratize celltherapy and ensure that every patient has an equal opportunity to receive the treatment that can save their lives, said Feinberg. Doing so requires innovation, passion and an entrepreneurial approach to the challenges at hand and we are excited to draw upon our 30 years of expertise as we embark on this next phase of our work.

About Gift of Life Marrow RegistryGift of Life Marrow Registry is a 501(c)(3) nonprofit organization headquartered in Boca Raton, Fla. The organization, established in 1991, is dedicated to saving lives by facilitating bone marrow and blood stem cell transplants for patients with leukemia, lymphoma, and other blood-related diseases. To learn more about Gift of Life Marrow Registry, visitwww.giftoflife.org.

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Stem Cells Market Detailed Analysis by On-going Trends, Prominent Size, Share, Sales and Forecast to 2025 – PRnews Leader

By daniellenierenberg

A succinct analysis of market size, regional growth and revenue projections for the coming years is presented in GlobalStem Cells Marketreport. The study further sheds light on major issues and the new growth strategies implemented by manufacturers that are part ofcompetitive landscape of the studied market.Thereport offers key trends, investment opportunities and drivers in Global Stem Cells Marketwith the latest market intelligence by adopting primary and secondary research methods. It also includes strategies adopted in the context of acquisitions and mergers, and business footprint extensions.

In order to provide more exactmarket forecast, the report comprises a complete research study and analysis ofCOVID-19 impact on the Global Stem Cells market. It also considers the strategies that can be adopted to deal with the situation.

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Competitive Landscape and Stem Cells Market Share Analysis:

The competitive landscape of the Stem Cells market provides data about the players operating in the studied market. The report includes a detailed analysis and statistics onprice, revenue and market share of the playersfor the period 2020-2025. The major players covered are as follows:

Thermo Fisher Scientific Inc.

Cellular Engineering Technologies Inc

Qiagen N.V

Sigma Aldrich Corporation

Becton, Dickinson and Company

Miltenyi Biotec

International Stem Cell Corporation

Stem Cell Technologies Inc.

Pluristem Therapeutics Inc

Medtronic, Inc

Zimmer Holdings, Inc.

Bio Time Inc

Zimmer Holdings, Inc

Orthofix, Inc.

Osiris Therapeutics Inc

Others Prominent Players

Key segments covered:

By Product

Adult Stem Cells

Neural Stem Cells

Hematopoietic Stem Cells

Mesenchymal Stem Cells

Umbilical Cord Stem Cells

Epithelial Stem cells and Skin Stem Cells

Others

Human Embryonic Stem Cells

Induced Pluripotent Stem Cells

Others

By Application

Regenerative Medicine

Neurology Regenerative Medicine

Oncology Regenerative Medicine

Myocardial Infraction Regenerative Medicine

Diabetes Regenerative Medicine

Hematology & Immunology Regenerative Medicine

Orthopedics Regenerative Medicine

Other Regenerative Medicine

Drug Discovery and Development

Other Applications

By Technology

Cell Acquisition

Bone Marrow Harvest

Umbilical Blood Cord

Apheresis

Others

Cell Production

Therapeutic Cloning

In-vitro Fertilization

Cell Culture

Isolation

Cryopreservation

Expansion and Sub-Culture

By End-User

Biopharmaceutical

Biotechnology Industry

Research Institutes

By Treatment Type

Allogeneic Stem Cell Therapy

Auto logic Stem Cell Therapy

Syngeneic Stem Cell Therapy

By Banking Type

Public

Private

By Region:

North America (U.S. & Canada)

Europe (Germany, United Kingdom, France, Italy, Spain, Russia, and Rest of Europe)

Asia Pacific (China, India, Japan, South Korea, Indonesia, Taiwan, Australia, New Zealand, and Rest of Asia Pacific)

Latin America (Brazil, Mexico, and Rest of Latin America)

Middle East & Africa (GCC, North Africa, South Africa, and Rest of Middle East & Africa)

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Some Important Highlights from the Report include:

Market CAGR during the 2020-2025 forecast period.

Comprehensive analysis on factors that will speed up the growth of Stem Cells marketover the next five years.

Precise estimates about the market size of global Stem Cells market and itscontribution to the parent market.

Precise forecasts for future developments in the Stem Cells industry and shifts in consumer behavior.

The growth of the Stem Cells Market across the Americas, APAC, Europe and MEA.

A detailed analysis of the industry competition and quantitative data on various vendors.

Comprehensive information on variables that will impede the growth of Stem Cells companies.

The Following are the Key Features of Global Stem Cells Market Report:

Market Overview, Industry Development, Market Maturity, PESTLE Analysis, Value Chain Analysis

Growth Drivers and Barriers, Market Trends & Market Opportunities

Porters Five Forces Analysis & Trade Analysis

Market Forecast Analysis for 2020-2025

Market Segments by Geographies and Countries

Market Segment Trend and Forecast

Market Analysis and Recommendations

Price Analysis

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Stem Cells Market Company Analysis: Company Market Share & Market Positioning, Company Profiling, Recent Industry Developments etc.

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Blood Cancer: Science Reveal Five Easily Missed Signs of Leukemia – Science Times

By daniellenierenberg

Experts diagnose someone with a blood cancerapproximately every three minutes in the United States. Every year, new blood cancer reports account for10 percent of new diagnoses of cancer.

There are typically three separate types of blood cancers, according toExpress.co.uk. These include leukemia, lymphoma, and myeloma. Signs and symptoms vary based on the form of blood cancer an individual has.

Major factors in leukemia survival rates include early diagnosis and management. Read on to find out more about some of the signs of early blood cancer that you can never miss.

(Photo : Dan Kitwood/Getty Images/Cancer Research UK)CAMBRIDGE, UNITED KINGDOM - DECEMBER 09: A fridge of chemical solutions which contain nutrients that are needed to 'feed' cells and keep them alive for laboratory experiments, at the Cancer Research UK Cambridge Institute on December 9, 2014 in Cambridge, England. Cancer Research UK is the world's leading cancer charity dedicated to saving lives through research. Its vision is to bring forward the day when all cancers are cured. They have saved millions of lives by discovering new ways to prevent, diagnose and treat cancer, and as such the survival rate in the UK has doubled in the last 40 years. Cancer Research UK funds over 4,000 scientists, doctors and nurses across the UK, more than 33,000 patients who join clinical trials each year and a further 40,000 volunteers that give their time to support the work.

According toHematology.org, most blood cancers begin in the bone marrow - where blood is made. These cancers disrupt the development and work of your blood. The stem cells transform into three types of blood cells-white, red, or platelets in the bone marrow.

When anyone has blood cancer, and irregular blood cell's development influences the regular output of blood cells. These cancer cells inhibit the regular functions of your blood such as preventing excessive bleeding or combating diseases. There are three major types of tumors in the blood: leukemia, lymphoma, and myeloma.

Leukemia is a disease that induces the massive development of irregular white blood cells in your blood marrow. This stops bacteria from being combated by the body. These cells often hinder platelets and red blood cells from being formed by the bone marrow.

Plasma cell cancer is myeloma. The antibodies in your body are produced by these white blood cells to combat and resist illnesses and diseases. This cancer can disrupt the immune system of your body and render you susceptible to infection.

Lymphoma hinders the lymphatic function that generates immune cells and removes the body from surplus fluids. Abnormal lymphocytes, along with other cells, can accumulate and gather in the lymph nodes. The body's immune system is weakened by these cancerous cells.

Blood cancer signs differ, like leukemia. Here are certain signs of blood cancer that you can look out for. Many of these signs may sound like the flu and maybe simple to ignore.

If the body produces leukemia, blood cells are destroyed by the disease, so it is impossible for your body to produce safe blood cells. You can experience anemia, and light skin is one of the major signs of anemia. Also, your hands can feel cold to the touch.

A typical symptom in certain diseases is exhaustion. You can see the doctor if you feel more worn out than usual and note a drastic difference in your energy.

Your blood cells aid the functioning of the immune system. The body's immune system does not normally work when certain cells are unhealthy, leading you to get sick more frequently. Frequent fevers and pneumonia are some of the most prominent first signs of leukemia.

You can also keep an eye on any shortness of breath if you are feeling energy depleted. You can take care if you feel short of breath any more quickly during physical exercise.

You can bleed more than usual because the body does not produce enough platelets. You might even more often get a bloody nose. Other modifications connected to your blood that you can look out for include:

No one is sure of what induces leukemia or other cancers of the blood, and there is no means of stopping it. Many factors in the environment, including smoking, pollution, and radiation, may lead to this disease's growth. The past of the family may also play a part in your chance of leukemia.

ALSO READ: Coronavirus Survivors Twice as Likely to Develop Mental Disorders - Study

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Human mesenchymal stromal cells do not express ACE2 and TMPRSS2 and are not permissive to SARS-CoV-2 infection – DocWire News

By daniellenierenberg

This article was originally published here

Stem Cells Transl Med. 2020 Nov 14. doi: 10.1002/sctm.20-0385. Online ahead of print.

ABSTRACT

Anti-inflammatory and immune-modulatory therapies have been proposed for the treatment of COVID-19 and its most serious complications. Among others, the use of mesenchymal stromal cells (MSCs) is under investigation given their well-documented anti-inflammatory and immunomodulatory properties. However, some critical issues regarding the possibility that MSCs could be infected by the virus have been raised. Angiotensin-converting enzyme 2 (ACE2) and type II transmembrane serine protease (TMPRSS2) are the main host cell factors for the Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2) entry but so far it is unclear if human MSCs express or do not these two proteins. To elucidate these important aspects, we evaluated if human MSCs from both fetal and adult tissues constitutively express ACE2 and TMPRSS2 and, most importantly, if they can be infected by SARS-CoV-2. We evaluated human MSCs derived from amnios, cord blood, cord tissue, adipose tissue and bone marrow. ACE2 and TMPRSS2 were expressed by the SARS-CoV-2-permissive human pulmonary Calu-3 cell line but not by all the MSCs tested. MSCs were then exposed to SARS-CoV-2 wild strain without evidence of cytopathic effect. Moreover, we also excluded that the MSCs could be infected without showing lytic effects since their conditioned medium after SARS-CoV-2 exposure did not contain viral particles. Our data, demonstrating that MSCs derived from different human tissues are not permissive to SARS-CoV-2 infection, support the safety of MSCs as potential therapy for COVID-19. AlphaMed Press 2020 SIGNIFICANCE STATEMENT: Human mesenchymal stromal cells (hMSCs) are currently under investigation for the treatment of COVID-19. However, the potential safety profile of hMSCs in this context has never been defined since none has described if they express ACE2 and TMPRSS2, the main host cell factors for SARS-CoV-2 entry, and if they can be infected by SARS-CoV-2. We provide the first evidence that ACE2 and TMPRSS2 are not expressed in hMSCs derived from both adult and fetal human tissues and, most importantly, that hMSCs are not permissive to SARS-CoV-2 infection. These results support the safety of MSCs as potential therapy for COVID-19.

PMID:33188579 | DOI:10.1002/sctm.20-0385

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Stanford coach’s quest to save his brother: ‘God, I hope this works’ – Scope

By daniellenierenberg

During a 2018 home game against Washington State University, David Shaw, Stanford's football coach, ambled slowly along the sideline, his joints aching.

Wanting to focus on the players and the game, he kept the reason for his lethargy to himself. But two years later, this past Saturday, the sports world learned the full story.

A College GameDay feature on ESPN revealed that the morning before the game, Shaw had been given stem-cell-inducing medication at Stanford Hospital. It was a first step in donating the cells to his brother, Eric Shaw, who was fighting a rare form of lymphoma.

In the opening of the six-minute video, Shaw says he thought, "'God, I hope this works, 'cause if it doesn't, I'm going to lose my brother.'"

Eric Shaw began noticing strange dark patches on his skin in 2011, the year his older brother became Stanford's head football coach. They were everywhere, from head to foot. Later, small tumors popped up all over his body.

"I would have itching attacks where I would end up actually tearing my skin," he says in the video. "I would still scratch at night and end up with bloody arms and legs."

Eric Shaw transferred his medical care to the Stanford Cancer Center in 2013. There, physicians told the financial services marketing professional that he needed to start radiation treatment immediately. It worked, but only briefly: Six months later, the cancer returned.

He was diagnosed with mycosis fungoides, a T cell lymphoma that affects fewer than four in a million people in the United States.

Shaw's physicians began discussing bone marrow transplant. David Shaw was tested as a donor, but he scored only 5 on a 10-point match scale. A worldwide search found closer matches, and Eric Shaw underwent radiation and chemotherapy to prepare for the transplant.

One attempt failed, then another.

"You think you've kind of pulled at the last thread, and there are no more threads, and all I could tell him was that I loved him and that I was there for him," David Shaw says in the video.

But the Stanford physicians had one last weapon: a haploidentical transplant. The recently developed technique uses stem cells, typically from a family member, that are less than a perfect match.

David Shaw underwent a five-day-long process at Stanford Hospital to donate the cells. He received medication that caused him to produce an abundance of stem cells, then gave blood from which the cells were extracted. Those cells were then transplanted into his brother.

This time, it worked.

After 52 days at Stanford Hospital, Eric Shaw finally went home on Nov. 25, 2018. The video shows him being wheeled out as medical staff members cheer him on.

Youn Kim, MD, who treated Eric and heads Stanford's multidisciplinary Cutaneous Lymphoma Clinic/Program, told ESPN: "If he didn't go for this risk, he wouldn't be here...He wouldn't be living."

As the article notes, Stanford physicians Wen-Kai Weng, MD, PhD, and Michael Khodadoust, MD, PhD, also were on the team treating Eric Shaw.

Today, nearly two years later, he remains cancer-free.

"Seven years of battling this disease, and it was over," he says in the video, tears running down his face. "A miracle."

David Shaw shares his brother's joy. As he told ESPN: "Every time I see him, I just smile, you know? Because he gets to be here."

Images of Eric Shaw, left, taken earlier this month, and his brother David Shaw, courtesy of the Shaw family, and Stanford Athletics

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Genenta’s Temferon: Evidence of Controlled and Targeted Interferon Expression in Preliminary Phase I/II Clinical Data in Glioblastoma MultiformeData…

By daniellenierenberg

MILAN, Italy and NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Genenta Science, a clinical-stage biotechnology company pioneering the development of hematopoietic stem progenitor cell immuno-gene therapy for cancer (Temferon), presents new preliminaryclinical data from a Phase I/IIa study of Temferon in patients affected by glioblastoma multiforme (GBM) at the 2020 Society for Neuro-Oncology (SNO) Annual Meeting, taking place November 19-22 in Austin, TX.

To date, ten patients were enrolled and eight were treated. Temferon was well tolerated, as suggested by the rapid hematological recovery and engraftment of modified cells observed in all the treated patients. No dose limiting toxicities were identified.

T-cell immunorepertoire changes were observed after treatment with evidence for clonal expansion, including tumor associated clones, suggesting a possible reset of T-cell responses, which are known to play a key role in the tumor-induced tolerance.

Interferon-alpha (IFN-) response was identified across a number of tumor infiltrating myeloid cells while a low concentration of IFN- was detected in the plasma and cerebrospinal fluid (CSF) of patients. This provides evidence that the Temferon built-in control mechanism is working to reduce the risk of IFN- off-target effects preserving the desired in situ biological effects.

Pierluigi Paracchi, Chairman and Chief Executive Officer at Genenta Science, said: These preliminary results are exciting indications of the feasibility, safety and local biological activity of our approach. The data are encouraging and in line with our pre-clinical results, with preliminary evidence of changes in the immune system and that Temferon is well tolerated without systemic toxicities.

Temferon-derived differentiated cells, as determined by vector copy number (VCN) in peripheral blood and bone marrow, were evident within 14 days of treatment and persist in peripheral blood in the long term (up to one year). Preliminary data on tumor specimens at second surgery confirmed the presence of TEMs and suggested that a higher IFN response gene signature may occur after treatment in stable lesions, compared to lesions that progress.

About Genenta Science

Genenta (www.genenta.com) is a clinical-stage biotechnology company pioneering the development of a proprietary hematopoietic stem cell gene therapy for cancer. Temferon is based on ex-vivo gene transfer into autologous hematopoietic stem/progenitor cells (HSPCs) to deliver immunomodulatory molecules directly via tumor-infiltrating monocytes/macrophages (Tie2 Expressing Monocytes - TEMs). TemferonTM, which is under investigation in a Phase I/IIa clinical trial in newly diagnosed Glioblastoma Multiforme patients, is not restricted to pre-selected tumor antigens nor type and may reach solid tumors, one of the main unresolved challenge in immuno-oncology. Based in Milan, Italy, and New York, USA, Genenta has raised more than 33.6 million (~$40 million) in three separate rounds of financing.

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It’s time for Kentucky to talk to expectant parents about benefits of cord blood banking – Courier Journal

By daniellenierenberg

Paula Grisanti, Opinion contributor Published 6:20 a.m. ET Nov. 9, 2020

This year, Nov.17 has been designated World Cord Blood Day, an annual event to raise awareness for the life-saving benefits of cord blood transplants while educating parents, health professionals and the general public about the need to preserve these precious cells.

Cord blood transplants are being used to treat more than 80 different diseases and conditions including blood cancers like leukemia and lymphoma, neuroblastoma (the most common cancer in infants), bone-marrow failure disorders, inherited blood disorders and rare immune system disorders. They are also showing new promise for conditions that have never had treatment options, like autism and brain injury.

The first cord blood stem cell transplant, an international effort between physicians in the U.S. and Europe, was performed in France in 1988. Stem cells collected from a newborns umbilical cord blood were used to save the life of her brother, a 5-year-old with Fanconi Anemia. Since then, there have been more than 40,000 cord blood transplants performed worldwide.

Now standard of care for cancers of the blood and a host of other life-threatening diseases, blood forming stem cells for transplantation can be collected from bone marrow, circulating bloodor a newborn babys umbilical cord blood. Some experts believe cord blood contains nearly 10 times the number of stem cells found in bone marrow.

Because umbilical cord stem cells are less mature than adult bone marrow stem cells, they are also less likely to be rejected and can be used when there isnt a perfect match.

Between these threeoptions, the easiest collection by far is from umbilical cord and placental tissue after a baby is born and the umbilical cord has been cut, at no risk to mother or child, in a process that typically takes 5 to 10 minutes. The cells are then frozen in liquid nitrogen and can be stored indefinitely in private or public cord blood banks.

To store your babys cord blood for use by your child and your family only, you make arrangements with a private cord blood bank ahead of delivery to collect and store the cells; the cost to you includes a collection fee of $1,500 to $2,000 and an annual storage fee of $100 to $125.

If you cant afford or dont wish to save your babys cord blood stem cells, you can donate them to a public cord blood bank at no cost to you or your family.

Its the equivalent of registering these potentially life-saving cells with the national bone marrow registry; they will be available to the families of other children who need to find a bone marrow match after a devastating diagnosis. Without information and education, however, 95% of all cord blood is discarded as medical waste.

Right now, there is no public cord banking option in Kentucky, although public cord blood banking is highly recommended by both the American Academy of Pediatrics (AAP) and the American Medical Association (AMA). There are fewer than 25 public or hybrid cord blood banks in the U.S., many limited to a specific geographic area. None of them include Kentucky.

The chances of finding a bone marrow match in your family are only about 25%, making the bone marrow and umbilical cord blood registries a lifeline in desperate situations. Odds are worse for African Americans and other ethnic minorities who are underrepresented on the registry and ethnicity matters in a bone marrow transplant.

Donating cord blood cells to a public bank adds to the library of cells that may save someones life and increases the chance of a match for all of us. Who benefits most? Children, patients with rare human leukocyte antigen (HLA) types and ethnic minorities.

We need to do two things: Make public cord blood banking an option in the commonwealth of Kentucky, and then encourage conversations between health care providers and expectant parents about preserving these life-saving cells.

There are 28 states with legislation that ask or mandates physicians to talk to expectant parents about cord blood banking. Kentucky is not one of them, but most of our surrounding states have such legislation in place.

Through a long-standing relationship between the National Stem Cell Foundationand world-renowned cord blood expert Dr. Joanne Kurtzberg, we have a path forward for training hospitals and collecting cells for storage at the Carolinas Cord Blood Bank (CCBB), one of the largest public cord blood banks in the world. Dr. Kurtzberg directs both the Pediatric Blood and Marrow Transplant (PBMT) program at Duke University and the CCBB.

She performed the worlds first unrelated cord blood transplant in 1993, paving the way for this now routine source of donor cells for children who need a bone marrow transplant and dont have a matched donor. She established the CCBB in 1998.

Paula Grisanti is CEO of the National Stem Cell Foundation.(Photo: provided)

While weve initiated discussions between Louisville hospital systems and the CCBB, we need to begin the process of education for parents, nursing and medical school students, residents, midwives, practicing OB-GYNs and the general public.

What a waste to discard these life-saving cells the future of current and developing therapies for disabling and life-threatening diseases depends on our ability to make sure that doesnt happen.

Dr. Paula Grisanti is CEO and a founding member of the National Stem Cell Foundation, headquartered in Louisville, Kentucky. She holds a D.M.D. and MBA from the University of Louisville and has been actively involved in new venture start-ups for most of her career.

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Actinium to Host KOL Call on November 11th Featuring Actimab-A AML Combination Trials – Salamanca Press

By daniellenierenberg

NEW YORK, Nov. 11, 2020 /PRNewswire/ --Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") today announced that it will host a CD33 program update featuring two key opinion leaders (KOLs) today, November 11th at 4:15 PM ET. The event will feature KOLs Dr. Ehab Atallah from the Medical College of Wisconsin, the senior investigator of the Actimab-A CLAG-M combination trial and Dr. Gary Schiller from the University of California Los Angeles Health, the principal investigator for the Actimab-A venetoclax combination trial as well as members of Actinium's management team. Both KOL's will review data that was included in abstracts accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting. They will also provide their perspectives on the treatment landscape and medical need each trial potentially addresses.

Actimab-A AML Combinations Update Call DetailsWebcast link:https://ir.actiniumpharma.com/presentations-webinarsDate: November 11, 2020Time: 4:15 PM ET

Dr. Ehab Atallah, MD, is a Professor of Medicine and Section Head of Hematological Malignancies at the Medical College of Wisconsin Division of Hematology and Oncology, specializing in leukemia and myelodysplastic syndromes at Froedtert Hospital. Dr Atallah, as senior investigator, will review the Phase 1 data from the Actimab-A CLAG-M combination trial in relapsed or refractory acute myeloid leukemia (R/R AML) that demonstrated 100% remission in the third and planned final dose cohort. Further, 83% of patients (10/12) who received 3 or fewer prior lines of treatment achieved CR or CRi. Notably, 70% of CR/CRi patients (7/10) were MRD negative indicating a deep remission with no detectable disease. Dr. Atallah will also discuss the trial data in the context of data available for other treatment options, including recently approved and novel agents in development, in the fit R/R AML population.

Dr. Gary Schiller, MD, is the Director of Bone Marrow/Stem Cell Transplantation and Professor of Hematology-Oncology at UCLA. Dr. Schiller, a well-published clinical investigator in acute and chronic leukemias and other hematologic malignancies, is the principal investigator on the Phase 1/2 clinical trial of Actimab-A and venetoclax. Dr. Schiller will discuss the lack of viable treatment options for R/R AML and the available opportunity for combination regimens such as Actimab-A plus venetoclax. Last week, the company announced that first-in-human data in this combination trial had been accepted for poster presentation at ASH in December. The trial is in the dose escalation phase with proof of concept data expected in 2021.

CD33 Program ASH Abstract Links

Oral Presentation Title: A Phase I Study of Lintuzumab Ac225 in Combination with CLAG-M Chemotherapy in Relapsed/Refractory AMLPublication Number: 165Link: https://ash.confex.com/ash/2020/webprogram/Paper137218.html

Poster Title: Lintuzumab-225Ac in Combination with Venetoclax in Relapsed/Refractory AML: Early Results of a Phase I/II StudyPublication Number: 2875Link: https://ash.confex.com/ash/2020/webprogram/Paper141132.html

About Actinium's CD33 Program

Actinium's CD33 program is evaluating the clinical utility of Actimab-A, an ARC comprised of the anti-CD33 mAb lintuzumab linked to the potent alpha-emitting radioisotope Actinium-225 or Ac-225. CD33 is expressed in the majority of patients with AML and myelodysplastic syndrome, or MDS, as well as patients with multiple myeloma. The CD33 development program is driven by data from over one hundred and twenty-five treated patients, including a Phase 1/2 trial where Actimab-A produced a remission rate as high as 69% as a single agent. This clinical data is shaping a two-pronged approach for the CD33 program, where at low doses the Company is exploring its use for therapeutic purposes in combination with other modalities and at high doses for use for targeted conditioning prior to bone marrow transplant.Actinium currently has multiple clinical trials ongoing including the Phase 1 Actimab-A CLAG-M and Phase 1/2 Actimab-A venetoclax combination trials and is exploring additional CD33 ARC combinations with other therapeutic modalities such as chemotherapy, targeted agents or immunotherapy.

About Actinium Pharmaceuticals, Inc. (NYSE: ATNM)

Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing ARCs or Antibody Radiation-Conjugates, which combine the targeting ability of antibodies with the cell killing ability of radiation. Actinium's lead application for our ARCs is targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a BMT or Bone Marrow Transplant, Gene Therapy or Adoptive Cell Therapy (ACT) such as CAR-T to enable engraftment of these transplanted cells with minimal toxicities. With our ARC approach, we seek to improve patient outcomes and access to these potentially curative treatments by eliminating or reducing the non-targeted chemotherapy that is used for conditioning in standard practice currently. Our lead product candidate, I-131 apamistamab (Iomab-B) is being studied in the ongoing pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning. The SIERRA trial is over seventy-five percent enrolled and positive single-agent, feasibility and safety data has been highlighted at ASH, TCT, ASCO and SOHO annual meetings. More information on this Phase 3 clinical trial can be found at sierratrial.com. I-131 apamistamab will also be studied as a targeted conditioning agent in a Phase 1 study with a CD19 CAR T-cell Therapy and Phase 1/2 anti-HIV stem cell gene therapy with UC Davis. In addition, we are developing a multi-disease, multi-target pipeline of clinical-stage ARCs targeting the antigens CD45 and CD33 for targeted conditioning and as a therapeutic either in combination with other therapeutic modalities or as a single agent for patients with a broad range of hematologic malignancies including acute myeloid leukemia, myelodysplastic syndrome and multiple myeloma. Ongoing combination trials include our CD33 alpha ARC, Actimab-A, in combination with the salvage chemotherapy CLAG-M and the Bcl-2 targeted therapy venetoclax. Underpinning our clinical programs is our proprietary AWE (Antibody Warhead Enabling) technology platform. This is where our intellectual property portfolio of over 100 patents, know-how, collective research and expertise in the field are being leveraged to construct and study novel ARCs and ARC combinations to bolster our pipeline for strategic purposes. Our AWE technology platform is currently being utilized in a collaborative research partnership with Astellas Pharma, Inc. Website: https://www.actiniumpharma.com/

Forward-Looking Statements for Actinium Pharmaceuticals, Inc.

This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.

Contacts:

Investors:Clayton RobertsonActinium Pharmaceuticals, Inc.crobertson@actiniumpharma.com

Hans VitzthumLifeSci Advisors, LLCHans@LifeSciAdvisors.com(617) 430-7578

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Bone Marrow Processing System Market Industry Outlook, Growth Prospects and Key Opportunities – The Daily Philadelphian

By daniellenierenberg

Bone marrow aspiration and trephine biopsy are usually performed on the back of the hipbone, or posterior iliac crest. An aspirate can also be obtained from the sternum (breastbone). For the sternal aspirate, the patient lies on their back, with a pillow under the shoulder to raise the chest. A trephine biopsy should never be performed on the sternum, due to the risk of injury to blood vessels, lungs or the heart.

The need to selectively isolate and concentrate selective cells, such as mononuclear cells, allogeneic cancer cells, T cells and others, is driving the market. Over 30,000 bone marrow transplants occur every year. The explosive growth of stem cells therapies represents the largest growth opportunity for bone marrow processing systems.Europe and North America spearheaded the market as of 2016, by contributing over 74.0% to the overall revenue. Majority of stem cell transplants are conducted in Europe, and it is one of the major factors contributing to the lucrative share in the cell harvesting system market.

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In 2016, North America dominated the research landscape as more than 54.0% of stem cell clinical trials were conducted in this region. The region also accounts for the second largest number of stem cell transplantation, which is further driving the demand for harvesting in the region.Asia Pacific is anticipated to witness lucrative growth over the forecast period, owing to rising incidence of chronic diseases and increasing demand for stem cell transplantation along with stem cell-based therapy.

Japan and China are the biggest markets for harvesting systems in Asia Pacific. Emerging countries such as Mexico, South Korea, and South Africa are also expected to report lucrative growth over the forecast period. Growing investment by government bodies on stem cell-based research and increase in aging population can be attributed to the increasing demand for these therapies in these countries.

Major players operating in the global bone marrow processing systems market are ThermoGenesis (Cesca Therapeutics inc.), RegenMed Systems Inc., MK Alliance Inc., Fresenius Kabi AG, Harvest Technologies (Terumo BCT), Arthrex, Inc. and others

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Angiocrine Bioscience Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to AB-205 (Universal E-CEL Cell Therapy) to…

By daniellenierenberg

SAN DIEGO, Nov. 11, 2020 /PRNewswire/ -- Angiocrine Bioscience Inc., a clinical-stage biopharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) granted the Regenerative Medicine Advanced Therapy (RMAT) designation for AB-205, for "the treatment of organ vascular niche injuries to prevent or reduce severe regimen-related toxicities (SRRT) in patients with Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL) undergoing high-dose therapy (HDT) and autologous hematopoietic stem cell transplantation".Based on its Phase 2 trial results, Angiocrine expects to initiate a single pivotal registration Phase 3 trial in 2021 involving leading cancer centers in North America and Europe.

Angiocrine Bioscience Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to AB-205

"The RMAT designation speaks to the clinical meaningfulness and the promising efficacy data and safety profile of AB-205 based on our Phase 1b/2 study.This is an important step in accelerating the development of AB-205 towards its first market approval," commented Paul Finnegan, MD, Angiocrine's CEO."We appreciate the thorough assessment provided by the FDA reviewers and the support from our partner, the California Institute for Regenerative Medicine."Angiocrine was awarded a $6 million grant from CIRM in 2019 for the clinical development of AB-205.

About Regenerative Medicine Advanced Therapy (RMAT) DesignationEstablished under the 21st Century Cures Act, the RMAT designation was established to facilitate development and expedite review of cell therapies and regenerative medicines intended to treat serious or life-threatening diseases or conditions. Advantages include the benefits of the FDA's Fast Track and Breakthrough Therapy Designation programs, such as early interactions with the FDA to discuss potential surrogate or intermediate endpoints to support accelerated approval.

About HDT-AHCT High-dose therapy and autologous hematopoietic cell transplantation (HDT-AHCT) is considered a standard-of-care therapy for patients with aggressive systemic Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL).Although efficacious and considered a potential cure, HDT-AHCT is associated with severe regimen-related toxicities (SRRT) that increase patient morbidity and risk for mortality, especially in the aging population. Effective prevention of SRRT may lead to more patients being eligible for a potential cure through HDT and stem cell transplantation.

About SRRT Consequences of Diffuse Injury to the Organ Vascular NichesThe human body is capable of renewing, healing and restoring organs.For example, the human oral-GI tract renews its lining every 3 to 7 days. Both the organ renewal and healing processes are dependent on organ stem cell vascular niches made up of stem cells, endothelial cells (cells that line blood vessels) and supportive cells.When tissues are injured, the vascular niche endothelial cells direct the stem cells, via angiocrine factor expression, to repair and restore the damaged tissue. This restorative capacity is most active during childhood and youth but starts to diminish with increasing age.HDT provided to eradicate cancer cells also cause diffuse, collateral damage to vascular niches of multiple healthy organs. In particular, the organs with the highest cell turnover (ones with most active vascular niches) are severely affected.Specifically, the oral-GI tract, dependent on constant renewal of its mucosal lining, starts to break down upon vascular niche injury.The mucosal breakdown can cause severe nausea, vomiting and diarrhea. In addition, the bacteria in the gut may escape into the circulation, resulting in patients becoming ill with endotoxemia, bacteremia or potentially lethal sepsis.HDT-related vascular niche damage can also occur in other organs resulting in severe or life-threatening complications involving the lung, heart, kidney, or the liver.Collectively, these complications are known as severe regimen-related toxicities or SRRT.SRRT can occur as frequently as 50% in lymphoma HDT-AHCT patients, with increased rate and severity in older patients.

About AB205AB-205 is a first-in-class engineered cell therapy consisting of proprietary 'universal' E-CEL (human engineered cord endothelial) cells.The AB-205 cells are intravenously administered after the completion of HDT on the same day as when the patient's own (autologous) blood stem cells are infused. AB-205 acts promptly to repair injured vascular niches of organs damaged by HDT.By repairing the vascular niches, AB-205 restores the natural process of tissue renewal, vital for organs such as oral-GI tract and the bone marrow. Successful and prompt organ restoration can prevent or reduce SRRT, an outcome that is beneficial to quality of life and cost reductive to the healthcare system.

About CIRMThe California Institute for Regenerative Medicine (CIRM) was established in November, 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure provided $3 billion in funding for California universities and research institutions.With over 300 active stem cell programs in their portfolio, CIRM is the world's largest institution dedicated to stem cell research. For more information, visit http://www.cirm.ca.gov.

About Angiocrine Bioscience Inc.Angiocrine Bioscience is a clinical-stage biotechnology company developing a new and unique approach to treating serious medical conditions associated with the loss of the natural healing and regenerative capacity of the body.Based on its novel and proprietary E-CEL platform, Angiocrine is developing multiple therapies to address unmet medical needs in hematologic, musculoskeletal, gastrointestinal, soft-tissue, and degenerative/aging-related diseases.A Phase 3 registration trial is being planned for the intravenous formulation of AB-205 for the prevention of severe complications in lymphoma patients undergoing curative HDT-AHCT.This AB-205 indication is covered by the Orphan Drug Designation recently granted by the US FDA.In addition, Angiocrine is conducting clinical trials of local AB-205 injections for the treatment of: (1) rotator cuff tear in conjunction with arthroscopic repair; and, (2) non-healing perianal fistulas in post-radiation cancer patients.

For additional information, please contact:

Angiocrine Bioscience, Inc.John R. Jaskowiak(877) 784-8496IR@angiocrinebio.com

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‘A heart of gold’: Rick Schwartz remembered for his commitment to family, community – CTV News

By daniellenierenberg

REGINA -- Saskatchewans hockey community is mourning the loss of Rick Schwartz, who died suddenly in his Regina home on Monday evening from a heart attack at age 59.

To the public, Schwartz is known as the father of a Stanley Cup champion. His son, Jaden, is a member of the St. Louis Blues who won the cup in 2019.

Schwartz is also known for the dedication that he and his wife, Carol, have for the Mandi Schwartz Foundation. It is named after their daughter who lost a public battle to cancer in 2011. The foundation has focused on advocating for bone marrow drives and donations.

However, to those closest to Schwartz, hes being remembered as a man who put family and community before anything.

FAMILYS FIRST

Ramona and Patrick Vigneron, who are long-time close family friends of the Schwartzes, say theyll remember Ricks jokes, smile and laughter the most.

And just how much he absolutely loves his family, Ramona said. He always said familys first.

Schwartz had three children: Jaden, Rylan and Mandi.

The two families would travel together, often to watch their children play hockey. Some of their trips took them to Colorado, North Dakota, St. Louis and Germany.

With the celebrations hed always include family and friends, Ramona said.

Whether it was during the kids minor hockey days in Wilcox or watching a Stanley Cup Championship, Schwartz always provided a fun time for those around him.

One of the most entertaining things you could do is watch a hockey game with Rick with one of the kids playing, Patrick said.

It was great watching games with Ricky because he got pretty emotional as he watched the boys and Mandi play, Ramona said. It was really part of Rickys life, you could just see him come to life watching the kids play.

BONE MARROW DRIVES

In honour of Mandi, the Schwartz family launched a foundation that is often involved in bone marrow drives in hopes of helping people who need a donor find their perfect match.

Rick was determined to make sure Mandis foundation continued on with the stem cells, and match program was very important, Ramona said.

Bone marrow drives continue at Yale University, where Mandi played. The St. Louis Blues also held a drive in 2013. Four years later, an 18-year-old woman was able to find her perfect match from a man who was swabbed at that Blues game.

The Schwartz family hosted both the donor and the recipient, both from the United States, in 2019 for the annual Run for Mandi in Saskatchewan.

ATHOL MURRAY COLLEGE OF NOTRE DAME

Rick and Carols three children all attended Athol Murray College of Notre Dame in their childhood and teenage years.

They participated in multiple sports, but hockey was the biggest. Its been about a decade since any of the kids played there, but the Schwartzes have always stayed involved in the community.

The great thing about Rick was that he loves hockey, Rob Palmarin, the president of Athol Murray College of Notre Dame, said. Hed still come out to our arena and would visit with our coaches who were the coaches of his sons and daughter, and our hockey staff. He was a frequent visitor to our arena so he was just one of the family.

After Mandis passing in 2011, the Schwartz family helped to honour her at the school.

The Schwartz family has set up an endowment fund and that supports a number of our female athletes, particularly hockey players, on an annual basis, Palmarin said. That came out of the tragedy of Mandi Schwartz dying of cancer in 2011. So its been almost a decade of them working to keep her memory alive.

Palmarin said Rick and Carol were role models of parents who had children playing hockey.

One of the mottos painted in the rink at Notre Dame reads Never Lose Heart.

That motto is painted up there not only as an inspiration to our student athletes when they practice and play, but its also an inspirational motto for all of us to remember the Notre Dame Hounds family, both living and deceased, Palmarin said. Rick is now going to be part of that.

RECENT MEMORIES

Most recently, Schwartz worked with the Saskatchewan Safety Council. Patrick worked there with him for the past five years.

Weve got a couple of projects on the board right now and Im not sure where theyre going to end up, but well try to make them work for him, Patrick said.

Ramona said right now, the Schwartz family is cherishing the time they were able to spend together over the summer.

One of the blessings of COVID-19 was that Rylan came home from Germany and then Jaden came home from St. Louis and they were with their parents for literally four months, Ramona said. Carol kept repeating these last few days it has been awesome how much time Rick got to spend with his sons for the last four months.

She said the memories of playing golf and cards will long be remembered by the family.

The death is a shock. Theres a lot of people who have been affected by Ricky and just how passionate he is, Ramona said. He has a heart of gold.

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TaiGen Partners with GPCR to develop Burixafor & Taigexyn(R) – PRNewswire

By daniellenierenberg

TAIPEI, Nov. 9, 2020 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") announced today that they have signed an exclusive agreement with GPCR Therapeutics, Inc. ("GPCR"), a leading Korean biotechnology company, for the continued development of Burixafor worldwide and the commercialization of Taigexyn (nemonoxacin) in South Korea.

Burixafor is a highly potent CXCR4 inhibitor currently under clinical development. It can be used as a stem cell mobilizer for hematopoietic stem cell transplantation and a chemosensitizer in hematological and solid tumors. It can also be used for stem cell collection in healthy individuals for personalized regenerative medicine. Taigexyn is a novel safe and effective antibiotic for the treatment of bacterial infections including those caused by drug-resistant bacteria.

Under the terms of the agreement, GPCR Therapeutics will be wholly responsible for the development, registration, and commercialization of Taigexyn in S. Korea and Burixafor worldwide. Apart from upfront fees, TaiGen will receive shares of GPCR Therapeutics as well as future milestone and royalty payments.

GPCR Therapeutics is a world leader in the field of GPCR heteromer science and hasproprietary expertise and technology applicable to the development of this class of anti-cancer targets. CXCR4 antagonism is a well-accepted avenue towards cancer therapy and GPCR Therapeutics is well experienced and possesses the necessary know-how to develop Burixafor in the oncology field.

Dongseung Seen, CEO of GPCR Therapeutics, said, "This collaboration with TaiGen, which is a leading biotech company engaged in innovative molecular-based platforms with strong R&D capabilities, will lead to a long-term strategic and productive partnership. Further, it is our goal that our work together will position us to be a pre-eminent developer of anti-CXCR4 oncology drugs."

Kuo-Lung Huang, Chairman and Chief Executive Officer of Licensor, said, "This agreement and collaboration with GPCR is a tremendous progress in the continued development of Burixafor. Through the collaboration with GPCR Therapeutics, a novel and effective treatment for cancer patients possessing CXCR4 heteromers is on the horizon while a highly effective antibiotic will enter the S. Korea market to address their unmet medical needs in the near future."

About Burixafor

A stem cell mobilizer, Burixafor, is TaiGen's first fully in-house developed product, a First-in-Class drug with an IND under US FDA. With a variety of potential applications in a number of disease indications, if proven effective in clinical trials, Burixafor will be able to address several unmet medical needs. The molecule is a potent and selective chemokine receptor antagonist which can rapidly mobilize stem cells and progenitor cells from the bone marrow into peripheral circulation. Burixafor also has potential application in chemosensitization treatment of leukemia patients, delaying relapse after chemotherapy.

About Taigexyn

Taigexyn is a novel non-fluorinated quinolone available in both oral and intravenous formulations. The oral formulation of Taigexyn have received market approval in Taiwan and mainland China shown activity against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA as well as quinolone-resistant Streptococcus pneumonia. TaiGen partnered with Zhejiang Medicaine Co., Holding Distribution, R-Pharm of Russia, Productos Cientficos S.A. de C.V., Luminarie Canada Inc. and GPCR Therapeutics, Inc. in 36 countries worldwide. In addition to the oral formulation, TaiGen granted NDA approval for intravenous formulation in Taiwan and is going to obtain the market approval in mainland China.

About GPCR Therapeutics, Inc.

Based in Seoul, S. Korea, GPCR Therapeutics is a biopharmaceutical company developing drugs based on the novel science of GPCR (G Protein-Coupled Receptor) heteromers. GPCR Therapeutics is specifically focused on the development of cancer therapeutics with a precision oncology approach.

About TaiGen Biotechnology

TaiGen Biotechnology is a leading research-based and market-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, China. In addition to Taigexyn and Burixafor, TaiGen has two other in-house discovered NCEs: TG-1000, a novel pan-influenza antiviral effective against influenza-A, influenza-B, avian flu H7N7, and Tamiflu-resistant viruses, and Furaprevir, a HCV protease inhibitor for treatment of chronic hepatitis infection. TG-1000 is currently in Phase 1 clinical study in China and is granted IND approval by FDA in the U.S., and Furaprevir is currently in Phase 3 clinical development.

SOURCE TaiGen

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CytoDyn Completes Second Non-dilutive $28.5 Million Convertible Note Financing with Conversion Rate at $10.00 Per Share Without Warrants to Help…

By daniellenierenberg

VANCOUVER, Washington, Nov. 11, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it completed an additional non-dilutive convertible debt offering with an institutional investor, which provides $25 million of immediately available capital. The note has a two-year maturity, bears interest at the rate of 10% per annum and is secured by all assets of the Company, excluding its intellectual property. The note may be converted at the option of the investor into shares of the Companys common stock at a conversion price of $10.00 per share.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, We are very pleased with the institutions demonstration of confidence and their understanding of leronlimabs positioning on its regulatory trajectory. This infusion of capital will enable us to accelerate efforts to file BLAs in Canada and the U.K. for leronlimab as a combination therapy for HIV patients with one dose (one 350 mg subcutaneous injection) per week. We continue to expedite enrollment in CD12 (currently at 260 patients), in addition to now accelerating a COVID-19 trial for long-hauler patients, who have no alternative therapy and are rapidly emerging as a widespread health concern. We are well-positioned to supply $2 billion worth of leronlimab to treat COVID-19, if emergency use authorization is approved in the next 2-4 months based on anticipated successful CD12 results.

About Coronavirus Disease 2019 CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. Enrollment continues in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals and clinics throughout the U.S., which are identified on the Companys website under the Clinical Trial Enrollment section of the homepage; an interim analysis on the first 195 patients was conducted mid-October and is expected to occur again after enrollment reaches 293 patients.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells.CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA met telephonically with Company key personnel and its clinical research organization and provided written responses to the Companys questions concerning its recent Biologics License Application (BLA) for this HIV combination therapy in order to expedite the resubmission of its BLA filing for this indication.

CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.

CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking StatementsThis press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company's clinical trials, (viii) the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CONTACTSInvestors: Michael MulhollandOffice: 360.980.8524, ext. 102mmulholland@cytodyn.com

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CytoDyn Completes Second Non-dilutive $28.5 Million Convertible Note Financing with Conversion Rate at $10.00 Per Share Without Warrants to Help...

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